FDA Adverse Event
Injury
Summary report: N
LIGAMAX-5MM ENDO CLIP APPLIER
MDR report key: 1048728
·
Received May 2, 2008
Report
- Report Number
- 1527736-2008-02707
- Event Type
- Injury
- Date Received
- May 2, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 10, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- FZP
- PMA / PMN Number
- K050344
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 05/02/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP CHOLE PROCEDURE, THE DEVICE WAS STUCK ON THE ARTERY. THE SURGEON WAS ABLE TO MANUALLY PULL THE HANDLES APART AND THEY OPENED, BUT THE JAWS REMAINED CLOSED. THE SURGEON HAD TO PULL THE DEVICE OFF THE ARTERY. THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGAMAX-5MM ENDO CLIP APPLIER | FZP | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |